Standards & Norms

No dead volume

A conical, thread end without seams for both the female and male thread of the connector or ball valve guarantees a connection with no dead volume. This in turn ensures that no bacteria can become lodged, media do not crystallise and dirt particles cannot adhere.

High temperature compatibility

Our versatile connector types are the ideal solution if you have to work with aggressive media at very high temperatures. The outstanding chemical properties, high operational reliability and special connection principles meet all the requirements for working with high-temperature media.

RoHS

The raw materials used by emtechnik meet the requirements of the RoHS directive 2002/95/EC, RoHS directive 2011/65/EU and RoHS del. directive 2015/863/EU. That means they contain no lead, cadmium, chromium VI, mercury or the flame retardants PBB and PDBE or the plasticisers DEHP, BBP, DBP and DIBP, and that such materials are also not used anywhere in the production process.

High Purity

emtechnik has had a clean room to DIN EN ISO 14644-1 class 5 since 1997 (since 2018 also class 7). This facility makes it possible to clean and assemble our products in a contamination-free atmosphere.

All of our products certified to conform to the high-purity standard undergo a carefully monitored production process at our works: For preparation for further processing in the clean-room, products we manufacture using either injection moulding or by mechanical means are first pre-cleaned in an ultrasound bath with an oil separator and a DI bath. In the clean-room itself, the products are cleaned a second time and dried in vacuum conditions. The products are then final assembled and quality controlled by specially trained employees.

All clean-room products are placed in special double-welded packaging for safe transport. This packaging is also filled with class 5.0 nitrogen.

We can pre-treat our products on request according to their intended application to achieve a silicon-free or oil and grease-free surface.

USP Class VI

The identified materials are available on request with approvals corresponding to the guidelines of USP Class VI (pharmaceutical approval). The U.S. Pharmacopeial Convention (USP) is a non-commercial organisation that develops the standards for the quality of medications and other medical products. The comprehensive tests of the biological responsiveness of elastomers, plastics and polymers with direct or indirect patient contact. The standards are divided into six classes. Class VI includes the strictest tests and is widely used and accepted in the pharmaceutical and medical products industry.

Sterile

PVDF and PFA are also suitable for hot steam sterilisation – the indispensable requirement for absolute sterility. PVDF is autoclavable with no concerns at 134 °C or can be sterilised with γ radiation while fully retaining its mechanical properties (maximum dosage 25 - 50 kGy). PVDF is non-toxic in the range <150°C and does not provide any breeding ground for microorganisms. The surface of PVDF behaves very similarly to glass.

Suitable for use in food products

The term "Suitable for use in food products" summarises materials that meet the provisions of the FDA and/or the European regulations of EC 1935/2004.

Many of our materials are available with approvals in line with the provisions of EU law or the FDA (U.S. Food and Drug Administration) regarding suitability for use in food products. The FDA is the regulatory agency of the United States of America for monitoring of foods and approval of drugs. It monitors the safety and effectiveness of human and animal medicines, biological products, medical products, foodstuffs and radiation-emitting devices. This applies to both products produced in the USA and imported products.

EC 1935/2004 defines uniform requirements in regards to packaging materials and objects that come in contact with food either directly or indirectly. They are intended to protect human health as well as consumer interests while ensuring that the products that are used can be sold everywhere in the European area.

Electrically conductive

To prevent electrostatic charges from accumulating, the high-performance plastics PP, PVDF and PTFE are equipped with electrically conducting particles, which therefore gives them a very low surface resistance of < 10³ Ω and < 10² Ω. For media that are sensitive to UV radiation, it is important for the materials to be dyed solid black to block all UV light. PVDF-EL and PTFE-EL materials are also UV-resistant. Our products in these materials thus ensure maximum safety combined with impressive chemical resistance property.

ADI Free

In order to avoid any contamination with animal constituents, such as BSE pathogens, in the production process, emtechnik offers products made from plastics classified as ADI-free.

Resistance to aggressive media

Plastics can come into contact with a very wide range of different liquids and chemicals during use. emtechnik products have long-term resistance to aggressive media in numerous applications and are also resistant in aggressive environments.